Label: PRO-39 UREA- urea cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 9, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Pro-39 Urea (Urea 39% Cream) Rx only
    For Topical Dermatological Use Only
    Rx Only - Caution: Federal Law restricts this product to sale by, or on the order of a licensed healthcare practitioner.

  • Pro-39 Urea Description

    Pro-39 Urea Cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.
    Each gram of Pro-39 Urea Cream contains:
    ACTIVE: 39% Urea in a cream base of:
    INACTIVES: Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Propylene Glycol, Dimethicone, Melaleuca Alternifolia (Tea Tree) Oil, Helianthus Annuus (Sunflower) Oil, Chamomilla Recutita (Chamomile) Extract, Carbomer, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.

    CHEMISTRY
    Urea is a diamide of carbonic acid with the following chemical structure:

    image description

  • Pro-39 Urea - Clinical Pharmacology

    Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

  • PHARMACOKINETICS

    The mechanism of action of topically applied Urea is not yet known.

  • INDICATIONS AND USES

    For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

  • Contraindications

    Pro-39 Urea Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients.

  • Warnings

    For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.

  • Precautions

    Stop use and ask a doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

  • PREGNANCY

    Pregnancy Category B

    Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Pro-39 Urea Cream should be given to a pregnant woman only if clearly needed.

  • NURSING MOTHERS

    It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Pro-39 Urea Cream is administered to a nursing woman.

  • Adverse Reactions

    Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

  • Pro-39 Urea - Dosage and Administration

    Apply Pro-39 Urea Cream to affected skin two to three times per day as needed or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by a physician. Best applied to affected areas immediately after showering and just before bedtime.

  • How is Pro-39 Urea Supplied

    Pro-39 Urea (39% Urea Cream) is supplied in:

    8oz (227gm) Jar NDC 72678-034-01

    Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]

    Manufactured for:
    Lifsa Drugs LLC, New Brunswick, NJ 08901

    Rx only

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL - 227 gm Jar Label

    Rx only

    NDC 72336-034-01

    Pro-39 Urea UREA 39% CREAM

    Smooth, Spreadable, Moisturizing

    Pro-39’s high amount of urea exhibits intensive keratolyic and peeling effects. Thoroughly nourishes, helping to prevent cracks, and drying of your skin.

    FOR TOPICAL USE ONLY

    Net WT. 8OZ (227 gm)

  • Packaging

    image

  • INGREDIENTS AND APPEARANCE
    PRO-39 UREA 
    urea cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72336-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA390 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72336-034-01227 g in 1 JAR; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2019
    Labeler - Lifsa Drugs Llc (081205160)